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Bit of a delay on Inclisiran due to unresolved facility inspection | Source: Novartis International AG
Basel, December 18, 2020 — The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors. “Novartis is confident in the quality of the regulatory submission for inclisiran, which includes a robust body of evidence related to efficacy and safety. We look forward to meeting with the FDA and our third-party manufacturing partner to discuss the feedback received and next steps,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “We are committed to bringing this potential first-in-class small interfering RNA cholesterol-lowering treatment to patients as soon as possible.” The European Commission (EC) recently granted Novartis marketing authorization for Leqvio® (inclisiran) in Europe on December 11, 2020. About inclisiran In the Phase III trials, inclisiran was well-tolerated1,2. The most common adverse events reported (≥3% of patients treated with inclisiran and occurring more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea1,2. Among those, injection site reactions were the most frequent ones. Those were generally mild and none were severe or persistent1,2. Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics. |
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Msg # | Subject | Author | Recs | Date Posted |
34934 | Re: Bit of a delay on Inclisiran due to unresolved facility inspection | Steve_382 | 0 | 12/19/2020 12:07:41 PM |
34957 | Re: Bit of a delay on Inclisiran due to unresolved facility inspection - Q2 to Q3 response planned | Steve_382 | 0 | 1/26/2021 5:45:57 PM |